ISSN: 2320-5407 Int. J. Adv. Res.

7(3), 1443-1451

Journal Homepage: -www.journalijar.com

Article DOI:10.21474/IJAR01/8779
DOI URL: http://dx.doi.org/10.21474/IJAR01/8779

RESEARCH ARTICLE

COMPARISON OF EFFICACY AND SAFETY OF INTRACERVICAL FOLEY’S CATHETER BALLOON

WITH INTRACERVICAL PROSTAGLANDIN E2 GEL (DINOPROSTONE) FOR INDUCTION OF
LABOUR.

Dr. Hemlata and Dr. Godawari Joshi.

Department of obstetrics and gynaecology, government medical college & dr. S. T. G. H. Haldwani.
……………………………………………………………………………………………………....
Manuscript Info Abstract
……………………. ………………………………………………………………
Manuscript History
Received: 20 January 2019
Final Accepted: 22 February 2019
Published: March 2019
Key words:-
Green‟s function, Fick‟s Law, Thermal
diffusivity, Thermal conductivity.
Introduction:Induction of labour is an intervention after 28 weeks of
gestation, intended to artificially initiate uterine contractions resulting
in the progressive effacement and dilatation of the cervix and ending in
vaginal delivery. Sometimes because of medical or obstetric
complications of pregnancy, cervical ripening and induction of labour
is often required. Induction of labour is indicated when the benefits to
either the mother or fetus outweigh those of continuing the pregnancy
[1].
Aim Of The Study:To compare efficacy and safety of intracervical
Foley‟s balloon catheter with intracervical prostaglandin E2 gel
(dinoprostone) for induction of labour.
Objectives:To compare cervical ripening, induction-delivery interval,
mode of delivery, maternal complications and fetal outcome by two
methods.
Materials And Methods:Prospective randomized controlled study.
SAMPLE SIZE- Each group 50, determined by statistical analysis.
Successful induction considered if the patient entered the active phase
of labour/ bishop score 6.
Result:In present study, both groups were comparable in age
distribution. In both the groups, most of the study subjects were
between the age group of 18-25 years (76% in pgE2 v/s 70% in Foley‟s
catheter group). Mean age in PGE2 gel group was 23.20±3.03 years
while Mean age in Intra-Cervical Foley‟s Catheter group was
23.92±3.11 years. Mean gestational age in PGE2 gel group was
39.12±1.33 weeks compared to 39.06±1.18 weeks in Intra-Cervical
Foley‟s Catheter group. At start of induction mean Bishop score was
1.62±1.10 in PGE2 gel group while it was 1.58±1.01 in Intra-Cervical
Foley‟s Catheter group. Deshmukh V et al also reported similar pre-
induction mean Bishop score (1.48±0.67 in Foley‟s Catheter group v/s
1.59±0.59 in pgE2 gel group). In our study, post-induction mean
Bishop score at 6 hours was 6.56±2.13 in PGE2 gel group while it was
4.70±2.21 in Intra-Cervical Foley‟s Catheter group. Mean change in
Bishop score between 0 to 6 hours was significantly higher in pgE2 gel
group (4.94±1.78) compare to Foley‟s catheter group (3.12±1.78). The
rate of LSCS in pgE2 gel group was 10% and 32% in Foley‟s catheter
group respectively. The induction delivery interval showed

Corresponding Author:- Dr. Hemlata. 1443

Address:-Department of obstetrics and gynaecology, government medical college & dr. S. T. G. H.
Haldwani.
ISSN: 2320-5407 Int. J. Adv. Res. 7(3), 1443-1451

significantly higher time in intracervical Foley‟s catheter groups. The

mean induction delivery internal was 13.80±3.83 hrs in Foley‟s group
and 9.65±2.13 hrs in PGE2 group. In our study, common maternal
complication observed were Intrapartum pyrexia (1 case in pgE2 gel
group and 8 cases in Foley‟s catheter group) and puerperal pyrexia (1
case in pgE2 gel group and 4 cases in Foley‟s catheter group). 1 case of
hyperstimulation was also seen in pgE2 gel group. Apart from that we
have not seen any other complication in mothers. The present study
shows that the fetal outcome results were also comparable in both the
groups.
Conclusion:The results of this trial tended to favor the prostaglandins
use over Foley catheter use. The main advantage of the PGE2 gel is
that early ripening of cervix, lesser caesarean rate and infection rate as
compared to the Foley‟s catheter while disadvantage is higher chances
of uterine hypertonicity or tachysystole. but Foley‟s catheter mimicked
the physiology of the labour onset more closely, resulting in a less
likelihood of hyperstimulation, fetal heart rate abnormalities and
postpartum hemorrhage.
Now, there is recent trend of reintroducing the mechanical methods like
the Foley catheter, as there is an availability of sterile devices,
controlling one of the principal contraindications- infection. Such
mechanical methods are advantageous in terms of their reversibility and
the reduced expenditure. But Foley‟s catheter has been linked with a
possibility of infections in some larger studies. Thus, tremendous
attention should be drawn towards carrying out aseptic measures while
it is being inserted, to avoid maternal and probable neonatal infections.

Copy Right, IJAR, 2019,. All rights reserved.

……………………………………………………………………………………………………....
Introduction:-
Induction of labour is an intervention after 28 weeks of gestation, intended to artificially initiate uterine contractions
resulting in the progressive effacement and dilatation of the cervix and ending in vaginal delivery. The incidence of
induction varies widely from 5-30%. The goal of Obstetric is a pregnancy that results in a healthy infant and a
healthy mother. For majority of women, labour starts spontaneously and results in vaginal delivery at or near term.
Sometimes because of medical or obstetric complications of pregnancy, cervical ripening and induction of labour is
often required. Induction of labour is indicated when the benefits to either the mother or fetus outweigh those of
continuing the pregnancy [1]. Common indications for labour induction include preeclampsia, premature rupture of
membranes, chorioamnionitis, intrauterine growth retardation, isoimmunization, maternal medical problems, fetal
demise, postdated pregnancy and oligohydramnios. The chief contraindications to labour induction are placenta
previa, transverse lie, prolapsed umbilical cord, active genital herpes infection, and pelvic structural deformities;
Cephalopelvic disproportion. Induction of labour should be simple, safe, effective and preferably non-invasive. The
success of induction depends to a large extent on the consistency, compliance and configuration of the cervix [2].
The unripe cervix thus remains a well recognized impedent to the successful induction of labour [3].

Therefore, cervical ripening or preparedness for induction should be assessed before a regimen is selected. Many
methods have been devised to ripen the cervix and this process has been described as preinduction cervical ripening.
Pharmacologic agents available for cervical ripening and labour induction include prostaglandins, misoprostol,
mifepristone and relaxin. Local application of Prostaglandin E 2 (PGE2 or Dinoprostone) has been in use for cervical
ripening since late 1960s. PGE2 administered intravaginally or intracervically, improves Bishop score and induction
to delivery time when compared to those of untreated controls. The local application of PGE 2 results in direct
softening of the cervix by a number of different mechanisms [4,5]. Uterine tachysystole and accompanying fetal
distress is reported following administration of PGE 2 in 1 to 5 percent of women [6].

The use of a cervical catheter also appears to be effective for cervical ripening & has been shown to shorten
induction to delivery interval, decrease caesarean section rate and increase the rate of spontaneous vaginal delivery
[7]. Different catheter balloon volumes ranging from 30 - 80ml and even double balloon catheter have been studied

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for cervical ripening [8]. The mechanical action of the Foley catheter, strips the fetal membranes from the lower
uterine segment and causes release of lysosomes in the decidual cells, part of which is phospholipase A. These lytic
enzymes act on phospholipase to form arachidonic acid which is converted to prostaglandin, thereby improving the
consistency and effacement of the cervix [9,10]. Failed inductions landing in caesarean section are expected in
closed and firm cervix that is difficult to distend[11]. The advantage of this method over the pharmacological
preparation includes simplicity of preservation, lower cost and reduction of side effects.

This study was planned to compare the efficacy and safety of 30 ml Intracervical Foley catheter balloon with that of
intracervical Dinoprostone gel for cervical ripening for induction of labour at term.

Inclusion Criteria-
1. Pregnant nulliparous women
2. Singleton fetus in cephalic presentation
3. Bishop score <4
4. Intact membranes
5. Patient giving consent

Exclusion Criteria-
1. Any active or purulent infection of lower genital tract
2. Spontaneous labour at start of planned induction
3. Abnormal CTG at start of induction
4. Scarred uterus such as previous caesarean section
5. Malpresentation in labour
6. Cephalopelvic disproportion
7. Severe asthma
8. Tumors occupying the pelvis
9. Major degree placenta previa
10. Carcinoma cervix
11. Active herpes, HIV infection
12. Patient not willing to participate in study

History taking from the patient included the last menstrual period, menstrual cycle regularity, past obstetric and
medical history. Clinical general examination of the patient done. Obstetric examination done. After correlating the
history, clinical findings and previous ultrasound findings, according to the indication, patient selection for induction
is done. After selecting the patients for study, their Bishop score assessed. Major degrees of cephalopelvic
disproportion ruled out.

Method Of Application
Intracervical Foley’s Catheter
Patient was placed in „lithotomy position‟, perineum and vagina cleansed with betadine solution. No.16 foley‟s
catheter was introduced into the endocervix by direct visualization or blindly by locating the cervix with the
examining fingers and guiding the catheter over the hand and fingers through the endocervix and into the potential
space between the amniotic membrane and lower uterine segment. The balloon reservoir was inflated with 30ml of
distilled water. The balloon was strapped to the inner aspect of one thigh with slight tension. Monitering done using
partograph. Bishop score reassessed after six hours and 12 hours. Foley‟s balloon catheter removed after 12 hours if
there is no expulsion. Method considered failure if labour doesn‟t starts after 3 doses. All patients received
prophylactic antibiotics.

Prostaglandin E2gel instillation

PGE2 gel – Cerviprime gel which contains 0.5 mg of PGE2 gel present in prefilled syringe was used. Monitoring of
fetal heart rate and uterine activity continuously. Gel introduced into the cervix as follows-Patient in lithotomy
position, perineum and vagina cleaned with betadine. Dinoprostone gel inserted using pre-filled syringe into the
endocervix just below the level of the internal os, care taken not to injure the membranes. Patient to remain
recumbent for 30 minutes after the procedure. Bishop score assessed after six hours after the procedure. Gel repeated
6 hrly upto a maximum of three doses unless the bishop score is >6 or regular painful uterine contractions <5
minutes have commenced.

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Partogram was used to monitor the progress of labour.

Successful induction considered if the patient entered the active phase of labour/ bishop score 6.

Discussion:-
The present study entitled “To compare safety and efficacy of intracervical Foley‟s catheter Ballon with
intracervical prostaglandin gel E2 (Dinoprostone) for induction of labour” was a prospective hospital-based study
conducted in nulliparous pregnant women with unfavorable cervix over 37 weeks of gestational age. The main
objective of study was to compare cervical ripening, induction-delivery interval, fetal outcome and mode of delivery
between both methods. 50 patients in each group were recruited and followed till neonatal outcome.

Approximately about 15% labours are induced. The pre-induction cervical ripening is associated with the success of
the induction in women with unfavorable cervix103. Labor induction in an unfavorable cervix is a different and a
lengthy procedure and it is tiring for both the mother and the Obstetrician. The different methods which are used for
cervical ripening are pharmacological methods like oxytocin, estrogens, mifepristone, PGE1, PGE2, etc. and non-
pharmacological (mechanical) methods like Foley‟s catheter, laminaria, amniotomy, etc 103.

When the labour onset occurs physiologically, the cervix ripens before the myometrial contractions start. The
intracervical placement of the Foley catheter induces the cervical ripening without inducing any uterine contractions,
while the prostaglandins affect the cervical ripening and the uterine contractions simultaneously.

In present study, both groups were comparable in age distribution. In both the groups, most of the study subjects
were between the age group of 18-25 years (76% in pgE2 v/s 70% in Foley‟s catheter group). Mean age in PGE2 gel
group was 23.20±3.03 years while Mean age in Intra-Cervical Foley‟s Catheter group was 23.92±3.11 years.

Ziyauddin F et al104 also compared the effectiveness and the safety of the transcervical Foley catheter and the
prostaglandin E2 (PGE2) gel for the induction of labor in 70 women with a previous one caesarean section, in J.N.
Medical College, Aligarh, (U.P), India. Mean age in their study was 25.09 years in Foley‟s catheter group while
26.12 in PGE2 gel group. Similar age distribution was reported by another study from India by Rajeswari A et al 105.
In contrast to our study little higher maternal age was reported by Masood et al 106 who conducted a prospective
quasi-randomised clinical trial which included 90 term pregnant women who were randomly assigned to receive
intracervical foley catheter, dinoprostone 3 mg tablets or misoprostol 25μg tablets vaginally to compare the efficacy,
safety and acceptability for induction of labor in women with previous one caesarean section at term. In this study,
mean age in Intra-Cervical Foley‟s Catheter group was 27.56±4.07 years while in PGE2gel group it was 27.53±3.89
years. It might be due to the fact that they have selected all women with one previous cesarean section.

Similar maternal age was reported by Deshmukh V et al107 who reported mean age in Foley‟s catheter group as
22.27±2.97 years while in Ziyauddin F et al it was 22.00±2.79 years. This study was conducted at GMCH,
Aurangabad from July 2005 to January 2008 to compare the efficacy of intra-cervical Foley‟s catheter with PGE2
gel for pre-induction cervical ripening and it included 200 participants in each group.

In our study, mean gestational age in PGE2 gel group was 39.12±1.33 weeks compared to 39.06±1.18 weeks in
Intra-Cervical Foley‟s Catheter group. Similar to our study, Ziyauddin F et al reported mean gestational age as 39.24
weeks in Foley‟s catheter group and 38.89 weeks in pgE2 gel group. Mean gestational age in study by Masood et al
reported as 39.8±1.03 weeks in Foley‟s catheter and 39.5±0.77 weeks in PGE2 gel group which is also comparable
to our study. Study by Rajeswari A et al also reported similar gestational weeks distribution.

Pre-induction Bishop score:

In present study, at start of induction mean Bishop score was 1.62±1.10 in PGE2 gel group while it was 1.58±1.01 in
Intra-Cervical Foley‟s Catheter group. Deshmukh V et al also reported similar pre-induction mean Bishop score
(1.48±0.67 in Foley‟s Catheter group v/s 1.59±0.59 in pgE2 gel group).

In contrast to our study Ziyauddin F et al reported mean bishop score at start of induction as 2.80 in Foley‟s catheter
group and 2.95 pgE2 gel group. The difference may be due to the fact because in our study we have taken study
subjects with Bishop score ≤4 at start of induction while in study by Ziyauddin F et al, they included study subjects
with Bishop score ≤6 at start of induction so higher values were obtained.

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Post induction Bishop score:

In our study, post-induction mean Bishop score at 6 hours was 6.56±2.13 in PGE2 gel group while it was 4.70±2.21
in Intra-Cervical Foley‟s Catheter group. It was significantly higher in pgE2 gel group compare to Foley‟s catheter
group.

Deshmukh V et al reported post-induction mean Bishop score at 6 hours as 7.04±1.72 in Foley‟s Catheter group v/s
7.08±1.87 in pgE2 gel group. Author reported no significant difference between both group at post induction.
Post-induction mean Bishop score at 12 hours in our study was 6.0 in PGE2 gel group while it was 7.58±3.11 in
Intra-Cervical Foley‟s Catheter group but at 12 hours this difference was statistically non-significant. Similar to our
study, Ziyauddin F et al reported mean bishop score at post induction at 12 hours as 7.45 in Foley‟s catheter group
and 6.95 in pgE2 gel group.

Change in Bishop score:

In present study, mean change in Bishop score between 0 to 6 hours was significantly higher in pgE2 gel group
(4.94±1.78) compare to Foley‟s catheter group (3.12±1.78). In study by Deshmukh V et al mean change in Bishop
score between 0 to 6 hours was comparable and no significant difference was observed between both group
(5.56±1.89 in Foley‟s Catheter group v/s 5.49±1.82 in pgE2 gel group).

Similar findings were reported by Fareed P et al who compared the efficacy of intracervical Foleys catheter and
intracervical PGE2 gel in preinduction cervical ripening in Srinagar from Mar 2011- Mar 2013 in 200 patients. In
this study improvement in the bishop‟s score in Group A was 5.3+1.1) and in Group B it was 5.1+1.1; however no
significant difference in the mean changes was observed.

Caesarean section rate and indications:

In present study, the rate of LSCS in pgE2 gel group was 10% and 32% in Foley‟s catheter group respectively. The
most common indication for LSCS in both the group was fetal distress. Foley‟s catheter group had 16 cases for fetal
distress and pgE2 gel Group had 4 cases of fetal distress. The rate of LSCS in our study is agreeable. There was
significant association of increased rate of cesarean section with the Foley's catheter usage. Similar findings were
observed by Kadam DA et al who reported that cesarean section rate for Foleys group was 26.08 % and that for
PGE2 group was 0% and this difference was statistically significant. Study by Rajeswari A et al reported similar
caesarean section rate in both group (21% in Foley‟s group v/s 19% in pgE2 gel group). Similar to our study, most
common indication in their study was also fetal distress. Group F had 9 cases for FD and Group P had 11 cases of
fetal distress. Rate of cesarean section reported in study by Deshmukh V et al was 14% in Foley‟s group and 18.5%
in pgE2 gel Group. In this study, cases of fetal distress were 8.5% in Foley‟s group and 10.5% in pgE2 gel group.
Alam A et al also reported higher cesarean section rate in both groups (21% in Foley‟s group and 19% in pgE2 gel
group). Author reported that LSCS was done for fetal distress in Foley‟s group for 9 cases and in pgE2 gel group for
11 cases. The other indications for LSCS being failure to progress (6 and 5 respectively and failure of induction (3
and 1 respectively).

Mean Induction-delivery interval:

The induction delivery interval showed significantly higher time in intracervical Foley‟s catheter groups. The mean
induction delivery internal was 13.80±3.83 hrs in Foley‟s group and 9.65±2.13 hrs in PGE2 group. In contrary to the
findings, Rajeswari A et al reported mean induction delivery internal as 16.01±5.5 hrs in Foley's group and
16.85±3.81 hrs in PGE2 group. Higher mean I-D internal was also reported by Deshmukh V et al (15.32 hrs in
Foley‟s group and 14.2 hrs in PGE2 group) and Masood A et al (19.93 hrs in Foley‟s group and 20.10 hrs in PGE2
group).

In the study done by Marta Jozwiak et al, they found that induction to delivery duration in PGE2 group was
significantly less as compared to Foleys group, P value was 0.0001. But in the study done by Azra Naseem et al they
found that the induction to delivery duration was significantly less in Foleys group as compared to PGE2 group with
P value 0.008.

Maternal complications:
In our study, common maternal complication observed were Intrapartum pyrexia (1 case in pgE2 gel group and 8
cases in Foley‟s catheter group) and puerperal pyrexia (1 case in pgE2 gel group and 4 cases in Foley‟s catheter
group). 1 case of hyperstimulation was also seen in pgE2 gel group. Apart from that we have not seen any other

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complication in mothers. Ziyauddin F et al also reported also reported 1 case of uterine hypertonicity and 1 case of
puerperal pyrexia in pgE2 gel group while 2 cases of puerperal pyrexia were seen in Foley‟s group but in contrary to
our study, 13 cases of PPH were also reported by author (5 in Foley‟s group and 8 in pgE2 gel group). Rajeswari A
et al did not found any case of infection but side effects associated with pgE2 gel like uterine hypertonicity and
tachysystole were reported in 4 & 2 cases respectively.

Fetal outcome:
Fetal outcome data showed no significant difference between Foley‟s catheter Group and pgE2 gel Group with
respect to NICU admission rate (6 and 6 respectively). Thus, the present study shows that the fetal outcome results
were also comparable in both the groups. Compare to our study, NICU admission rate was very high in study by
Deshmukh V et al (18.5% in Foley‟s group v/s 20.5% in pgE2 gel group) but no significant difference was reported.
Similar to present study, Rajeswari A et al also reported lesser NICU admission rate (12% in Foley‟s group v/s 5% in
pgE2 gel group) and both groups were found to be comparable. 5 Cases in Foley‟s group and 4 cases in pgE2 gel
group were admitted to NICU in study by Masood A et al.

In our study, PGE2 gel produced better effects compare to Foley‟s catheter in the ripening of the cervix in women at
6 hrs but both were comparable at 12 hrs. The main advantage of the PGE2 gel is that early ripening of cervix, lesser
caesarean rate and infection rate as compared to the Foley‟s catheter while disadvantage is higher chances of uterine
hypertonicity or tachysystole.

Ravasia DJ et al conducted a study on the VBAC induction and showed that the Foley catheter induction was
associated with a lowest rupture rate in the induced TOL group and that it was comparable to the results in the
spontaneous TOL group. The PGE2 exposure during the TOL was associated with more than a 6fold increase in the
uterine ruptures as compared to that in the spontaneous labour.

In the large NICHD study, the use of the prostaglandin-based medications to induce labour was associated with a
nonsignificant increase in the risk of the uterine rupture as compared to the mechanical methods of induction of
labour (such as the use of a Foley catheter). In this study, the risk of the uterine rupture was 140/10,000 inductions
with the use of prostaglandins as compared to the 89/10,000 inductions with the use of a Foley catheter to dilate the
cervix.

According to an open label randomized control trial which was done by the PROBAAT study group, in women with
unfavorable cervices at term, the induction of labour with a Foley catheter was similar to the induction of labor with
the Prostaglandin E2 gel, with fewer maternal and neonatal side effects.

Result:-
CHARACTERSTIC Intracervical PGE2 gel Intracervical Foley catheter group P value
group
1. Mean age 23.20±3.03 23.92±3.11 0.49
2. Cases G1 84% G1 86% 0.73
according
gravida G2 12% G2 8%

G3 4% G3 6%

3. Cases 37-37wk+6d 14.0%

37-37wk+6d 14% 0.74
according to
gestational 38-38wk+6d 20.0%
38-38wk+6d 18%
age (in
weeks) 39-39wk+6d 24.0%
39-39wk+6d 26%

40-40wk+6d 26.0%
40-40wk+6d 30%

41-41wk+6d 14.0%
41-41wk+6d 11%

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42wks 2.0%
42wks 1%

0 14% 0.95
0 12%
1 40%
1 42%
2 20%
2 24%
3 22%
3 20%
4 4%
4 2%
4. Bishop
score at 0
hour
5. Bishop ≤5 26.0% <0.01
score at 6
hours 6-10 72.0%
>10 2.0%

6. Bishop ≤5 ≤5 0.0 0.03 34.9

score at 12
hours 6-10 6-10 100.0 39.5
>10 >10 0.0 25.6
*52 patients delivered
before 12 hours

7. Change in 0-2 0-2 10.0

Bishop
score 3-5 3-5 56.0
between 0 >5 >5 34.0 <.01
to 6 hours
8. Change in 0-2 0-2 0.0 0.02
Bishop
score 3-5 3-5 100.0
between 6 >5 >5 0.0
to 12 hours

9. Mean Bishop score at 0 hours 1.58 1.62 0.91

Bishop Bishop score at 6 hours 4.70 6.56 <0.01
score
Bishop score at 12 hours 7.58 6.00 0.54
3.12
Change in Bishop score between 4.94 <0.01
0 to 6 hours 3.56 0.82
Change in Bishop score between 3.20
6 to 12 hours
10. Mode of LSCS 32.0 10.0 0.01
delivery
Vaginal delivery 68.0 90.0

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11. Indication Fetal distress 100.0% 80.0% 0.23

of LSCS
Meconium stained liquor 0.0% 20.0%

12. Induction <6 hours <6 hours

88.0 <0.01
to active
labor 6-12 hours 6-12 hours
12.0
interval >12 hours >12 hours
0.0

13. Induction 6-12 hours 6-12 hours

92.0 <0.01
to delivery
interval >12 hours >12 hours
8.0

14. Interval Interval between InductionMean-

to active Mean- <0.01
between labor (In hours) 6.55 3.15
<0.01
Induction Interval between Induction 13.80
to delivery 9.65
to active (in hours)
labor and
delivery
15. Maternal Hyperstimulation 0.0 2.0 0.98
complicatio
ns PPH 0.0 0.0 -
Intra partum pyrexia 16.0 2.0 0.03
Puerperal pyrexia 8.0 2.0 0.36
Wound sepsis 0.0 0.0 -
16. NICU Yes 12.0 12.0 -
admission
No 88.0 88.0

Data entry and statistical analysis:

The collected data were transformed into variables, coded and entered in Microsoft Excel. Data were analyzed and
statistically evaluated using SPSS-PC-19 version.

Quantitative data was expressed in mean, standard deviation and difference between two comparable groups were
tested by student „t‟ test or Mann Whitney „U‟ test while qualitative data were expressed in percentage. Difference
between the proportions were tested by chi square test. „P‟ value less than 0.05 was considered statistically
significant.

Result:-
In present study, both groups were comparable in age distribution. In both the groups, most of the study subjects
were between the age group of 18-25 years (76% in pgE2 v/s 70% in Foley‟s catheter group). Mean age in PGE2 gel
group was 23.20±3.03 years while Mean age in Intra-Cervical Foley‟s Catheter group was 23.92±3.11 years. Mean
gestational age in PGE2 gel group was 39.12±1.33 weeks compared to 39.06±1.18 weeks in Intra-Cervical Foley‟s
Catheter group. At start of induction mean Bishop score was 1.62±1.10 in PGE2 gel group while it was 1.58±1.01 in
Intra-Cervical Foley‟s Catheter group. Deshmukh V et al also reported similar pre-induction mean Bishop score
(1.48±0.67 in Foley‟s Catheter group v/s 1.59±0.59 in pgE2 gel group). In our study, post-induction mean Bishop
score at 6 hours was 6.56±2.13 in PGE2 gel group while it was 4.70±2.21 in Intra-Cervical Foley‟s Catheter group.

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Mean change in Bishop score between 0 to 6 hours was significantly higher in pgE2 gel group (4.94±1.78) compare
to Foley‟s catheter group (3.12±1.78). The rate of LSCS in pgE2 gel group was 10% and 32% in Foley‟s catheter
group respectively. The induction delivery interval showed significantly higher time in intracervical Foley‟s catheter
groups. The mean induction delivery internal was 13.80±3.83 hrs in Foley‟s group and 9.65±2.13 hrs in PGE2
group. In our study, common maternal complication observed were Intrapartum pyrexia (1 case in pgE2 gel group
and 8 cases in Foley‟s catheter group) and puerperal pyrexia (1 case in pgE2 gel group and 4 cases in Foley‟s
catheter group). 1 case of hyperstimulation was also seen in pgE2 gel group. Apart from that we have not seen any
other complication in mothers. The present study shows that the fetal outcome results were also comparable in both
the groups.

Summary And Conclusion:-

The results of this trial tended to favor the prostaglandins use over Foley catheter use but further more study needed
for this as the process of Foley‟s catheter mimicked the physiology of the labour onset more closely, resulting in a
less likelihood of hyperstimulation, fetal heart rate abnormalities and postpartum hemorrhage.

Now, there is recent trend of reintroducing the mechanical methods like the Foley catheter, as there is an availability
of sterile devices, controlling one of the principal contraindications- infection. Such mechanical methods are
advantageous in terms of their reversibility and the reduced expenditure. But Foley‟s catheter has been linked with a
possibility of infections in some larger studies. Thus, tremendous attention should be drawn towards carrying out
aseptic measures while it is being inserted, to avoid maternal and probable neonatal infections.

Refrences:-
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